经合组织-407 驱动的28天重复剂量非临床安全评估
Acharya Balkrishna1,2,3, Swati Haldar1, Anurag Varshney1,2,4
1Drug Discovery and Development Division, Patanjali Research Institute, Governed by Patanjali Research Foundation Trust, Haridwar, Uttarakhand, India.
Frontiers in pharmacology
|June 5, 2023
概括
在老鼠中评估了Tinospora cordifolia水性提取物 (TCWE) 的毒性. 该研究发现TCWE高达1000mg/kg/天的安全性,确定其用于药物用途的非临床安全性.
科学领域:
- 药理学 药理学是指药理学的学科.
- 毒理学 毒理学 毒理学
- 植物医学 植物医学
背景情况:
- 丁花 (Tinospora cordifolia) 是一种传统的阿育吠陀草药.
- 最近的案例研究表明潜在的毒性,需要严格的安全评估.
研究的目的:
- 在Sprague-Dawley大鼠中进行Tinospora cordifolia水性提取物 (TCWE) 的28天重复剂量毒理学评估.
- 根据经合组织407指南,确定没有观察到的不良影响水平 (NOAEL).
主要方法:
- 在28天的时间里,TCWE在100,300和1000毫克/公斤/天的口服剂量被给予大鼠.
- 包括卫星组进行14天的恢复评估.
- 综合毒理学评估,包括临床症状,血液学,临床化学和组织病理学.
主要成果:
- 在高达1000mg/kg/day的剂量下,TCWE被认为是安全的,没有观察到死亡率或不良影响.
- 在临床症状,眼睛,血液学,尿液分析或临床化学参数中没有发现有毒性表现.
- 14天的恢复期没有显示任何不良影响,证实了安全性.
结论:
- 对于TCWE,没有观察到的不良影响水平 (NOAEL) 已确定为1000 mg/kg/day.
- 这项研究证实了Tinospora cordifolia传统的安全使用,并支持进一步的临床研究.
关键词:
14天的恢复期可以恢复.28天的重复剂量毒性28天的重复剂量毒性这是GLP,GLP就是GLP.经合组织 407 经合组织 407 经合组织青花皮 (Tinospora cordifolia) (野生) 是一种植物. .f.f. 的意思. & 森 (吉洛伊) 公司艾尤尔韦达是一种医学.更多相关视频
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